Policy & Regulation
AstraZeneca reports grant of Priority Review in the US for Lynparza for HRR-mutated metastatic castration-resistant prostate cancer
21 January 2020 -

Science-led biopharmaceutical company AstraZeneca Plc (STO:AZN) (LON:AZN) (NYSE:AZN) and pharmaceutical company MSD Inc (Merck & Co Inc in US and Canada) (NYSE:MRK) announced on Monday that a supplemental New Drug Application for Lynparza (olaparib) has been accepted and granted Priority Review in the US for patients with metastatic castration-resistant prostate cancer (mCRPC) and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations, who have progressed following prior treatment with a new hormonal agent.

Also, a Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020.

Reportedly, this Priority Review by the US Food and Drug Administration (FDA) is based on results from the phase III PROfound trial, which were presented during the Presidential Symposium at the 2019 European Society of Medical Oncology congress.

Results of the PROfound trial showed Lynparza significantly reduced the risk of disease progression or death by 66% based on a hazard ratio of 0.34 (p